D-0236-2026 Class III Ongoing
FDA drug recall D-0236-2026 was initiated by SOMERSET THERAPEUTICS LLC on Nov 26, 2025 and is designated Class III. Reason for recall: Subpotent product:out of specification assay results observed during long term stability testing. The recall status is ongoing. Affected quantity: 52,340 5mL vials.
Recall Details
- Product Type
- Drugs
- Report Date
- Dec 24, 2025
- Initiation Date
- Nov 26, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 52,340 5mL vials
Product Description
Cisatracurium Besylate Injection USP, 10 mg/5 mL* (2mg/mL), 10 x 5 mL Single-dose Vials per Carton, Rx Only, Manufactured for: Somerset Therapeutics, LLC, Hollywood, FL 33024, Made in India, Single-dose 5 mL vial NDC 70069-141-01; 10x5 mL single dose vial per Carton NDC 70069-141-10.
Reason for Recall
Subpotent product:out of specification assay results observed during long term stability testing.
Distribution Pattern
Nationwide in the USA
Code Information
Lot#: A240438, Exp Date 1/31/26, A250125, Exp Date 8/31/26
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0236-2026
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026